Optic Coherence Tomography in Patients With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Change in retinal layer thickness parameters over 3 and 6 months in ALS patients
研究概览
简要总结
Amyotrophic Lateral Sclerosis (ALS) is an adult-onset, devastating, neurodegenerative disease characterized by the loss of cortical, brain stem, and spinal motor neurons. Visual evoked potentials studies in patients with ALS suggest visual pathway involvement. Optic coherence tomography (OCT) is a non-invasive cross-sectional imaging modality measuring the optical reflections in biological tissues. The main objective of this observational cohort study is to explore the correlation between changes on OCT retinal parameters and and clinical disability as measured by the ALS Functional Rating Scale (ALS-FRS-r) in patients with ALS at baseline, 3 and 6 months. A secondary objective is to explore the correlation between changes in retinal OCT parameters and pulmonary function tests (FVC and FEV1) in this cohort of patients with ALS. A parallel cohort of healthy age and sex matched subjects will participate as controls to obtain reference values of their retinal layers' thickness at baseline, 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of ALS according to the El Escorial criteria.
- •Age 18 years to 80 years old
- •Disease duration less than 36 months
- •Patients logistically able to attend and be evaluated at baseline, 3 and 6 months
排除标准
- •Patients with diabetes mellitus
- •Patients with glaucoma, refractive errors of ± 6 diopters or more, or other ophthalmologic disorders such as media opacities that could interfere with retinal OCT assessment
研究组 & 干预措施
Patients with Amyotrophic lateral sclerosis
Patients diagnosed with amyotrophic lateral sclerosis
干预措施: Optic coherence tomography (Diagnostic Test)
Patients with Amyotrophic lateral sclerosis
Patients diagnosed with amyotrophic lateral sclerosis
干预措施: Pulmonary function test (Diagnostic Test)
Control
Parallel cohort of healthy age and sex matched subjects
干预措施: Optic coherence tomography (Diagnostic Test)
Control
Parallel cohort of healthy age and sex matched subjects
干预措施: Pulmonary function test (Diagnostic Test)
结局指标
主要结局
Change in retinal layer thickness parameters over 3 and 6 months in ALS patients
时间窗: 6 months
Observing the change in retinal layers thickness parameters in micrometers in ALS patients from baseline to 3 and 6 months
次要结局
- Comparison of changes in retinal layer thickness parameters over 3 and 6 months between ALS patients and their healthy controls(6 month)
- Correlation between changes in retinal layers thickness and ALS-FRS scores in patients with ALS(6 month)
- Correlation between changes in retinal layers thickness and Pulmonary function test parameters in ALS patients over 3 and 6 months(6 month)
研究者
Achraf Makki
Assistant professor
American University of Beirut Medical Center